Harmony Cone

Department of Health and Human Services	Public Health Service Food and Drug Administration
	10903 New Hampshire Avenue Silver Spring, MD 20993

FEB 17 2010

WARNING LETTER

VIA FEDERAL EXPRESS {AND FACSIMILE}

Michelle Harmony

Owner

Harmony Cone

3318 Highway #5, #410

Douglasville, Georgia 30135

Dear Ms. Harmony:

The Food and Drug Administration (FDA) has learned that your firm is marketing Harmony Cone ear candles in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).

Under section 201(h) of the Act, the Harmony Cone ear candle is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is in ended to affect the structure or function of the body, 21 U.S.C. 321 (h). The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from FDA before they may offer them for sale.

The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed your web site www.harmonycone.com. Based on the labeling for the Harmony Cone ear candles, for example, it appears your ear candles are intended to mitigate or treat allergies, headaches, colds, flu, sinus congestion, sore throat, ear infections, swollen glands, sinus infections, balance and equilibrium, migraines and vertigo.

A review of our records reveals that you have not obtained marketing approval or clearance before you began offering your product for sale, which is a violation of the law. Specifically, the Harmony Cone ear candle is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency under Title 21, Code of Federal Regulations (CFR) 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.

Your devices are also misbranded under sections 502(a), 502(f)(1), and 502(j) of the Act, 21 U.S.C. 352(a), 352(f)(1), and 352(j), respectively. Specifically, your devices are misbranded under section 502(a) of the Act, 21 U.S.C. 352(a), because the labeling, represents the ear candles as safe and effective for their intended uses, including the relief of various disorders as described above. For example, your website states that the Harmony Cone ear candle, "has a very consistent track record of success. [Sic] Helping people with the following problems: sinus congestion, colds, the flu, sore throats, earaches, ear infections, sinus infections, lymphatic congestion, swollen glands...." Your devices are misbranded under section 502(f)(1) of the Act, 21 U.S.C. 352(f)(1), because the labeling fails to bear adequate directions to assure the safe use of the car candles for the purposes for which they arc intended. Your devices are misbranded under section 502(j) of the Act, 21 U.S.C. 352(j), because the devices are dangerous to health when used in the manner or with the frequency or duration prescribed, recommended, or suggested in the labeling. A review of our records reveals that FDA has received medical device reports consistent with the danger to health posed by your device when used in the manner or with the frequency or duration prescribed, recommended, or suggested in the label, including reports involving ruptured tympanic membranes and burns as a result of the use of ear candles. Further, FDA is aware that these devices may be promoted for use in children of any age, including babies, putting them at increased risk for injuries and complications. Your website indicates that you market a product called Baby Ear Candles which, according to the labeling, is intended for use in the pediatric population.

You should take prompt action to correct these deviations. FDA requests that Harmony Cone immediately cease marketing, promoting and distributing Harmony Cone ear candles. This includes the removal of Harmony Cone ear candles and references to ear candling from your website www.harmonycone.com. Failure to promptly correct these deviations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to seizure, injunction, and/or civil money penalties. Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.

Please let this office know in writing what steps you have taken to correct the problem within fifteen (15) working days from the date you received this letter. We also ask that you explain how you plan to prevent this from happening again. If you need more time, let us know why and when you expect to complete your correction. Please direct your response or any questions you may have to Debra Demeritt at the Food and Drug Administration, 10903 New Hampshire Avenue, Building 66, Room 3546, Silver Spring, Maryland 20993, facsimile at 301-847-8137.

Finally, you should understand that there are many FDA requirements pertaining to the manufacture and marketing of devices. This letter pertains primarily to the issue of premarket review for your device and does not necessarily address other obligations you have under the law.

Sincerely,

/S/

Timothy A. Ulatowski

Director

Office of Compliance

Center for Devices and

Radiological Health

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